Impureza 27 de citalopram (sal de cloruro) es una impureza identificada en procesos de síntesis y almacenamiento que requiere control específico dentro del perfil de impurezas. Su detección y cuantificación se realiza mediante HPLC con validación de método y confirmación por LC-MS y RMN para identificación estructural. Presenta solubilidad y comportamiento cromatográfico característicos que pueden interferir en la pureza del principio activo | por lo que se establecen límites de aceptación conforme a ICH Q3A/Q3B y se implementan procedimientos de mitigación en el desarrollo y liberación de lotes. Proporciona datos críticos para garantía de calidad y trazabilidad analítica.
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